Evaluation of the Effectiveness of a Quality Improvement Intervention

• ClinicalTrials.gov Identifier: NCT04278612
• Recruitment Status: Completed
• First Posted: February 20, 2020
• Last Update Posted: February 20, 2020
• Sponsor: University of KwaZulu
• Collaborators: UNICEF; Institute for Healthcare Improvement
• Information provided by (Responsible Party): Christiane Horwood, University of KwaZulu

Study Description

Brief Summary:

This rigorous evaluation demonstrated that implementation of a time-limited quality improvement strategy effectively improved coverage of some components of an integrated maternal and child health service in a complex health environment, but we were unable to achieve the changes needed to provide a comprehensive package of care for mothers and children.

Condition or disease	Intervention/treatment	Phase
Maternal and Child Health	Other: Quality improvement intervention to strengthen health service provision	Not Applicable

Detailed Description:

Background: Despite policies and guidelines recommending integration of health services in South Africa, provision of maternal and child health services remains fragmented. This study evaluated a rapid, scaleable, quality improvement intervention to improve integration of maternal and child health and HIV services at a primary health level, in KwaZulu-Natal, South Africa.

Methods: A three-month intervention comprised of six quality improvement mentoring visits, learning sessions with clinic staff to share learnings, and a self-administered checklist aimed to assist health workers monitor and implement an integrated package of health services for mothers and children. The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics between December 2016-February 2017. A multi-level, mixed effects logistic regression was used to account for random cluster fixed time and group effects using Stata V13.1.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1438 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The study evaluated 27 clinics in four sub-districts using a stepped-wedge design. Each sub-district received the intervention sequentially in a randomly selected order. Five waves of data collection were conducted in all participating clinics
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of the Effectiveness of a Quality Improvement Intervention to Support Integration of Maternal, and Child and HIV Care in Primary Health Care Facilities in South Africa
• Actual Study Start Date: January 18, 2016
• Actual Primary Completion Date: February 5, 2017
• Actual Study Completion Date: January 16, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Provision of comprehensive care including the following: Baby: Measure weight and length Plot on appropriate growth charts in Road to Health Card (RTHC) Discuss with mother about the growth of the baby Identification of malnutrition and appropriate management Age-appropriate nutrition counselling Immunisation Developmental screening Vitamin A supplementation Deworming HIV Care: If mother is HIV positive -; Polymerase chain reaction (PCR) test for the baby repeated at 10 weeks; Nevirapine for the baby for six weeks Mother: Cervical cancer screening Provide family planning Screening tuberculosis (TB) and sexually transmitted infections (STIs) HIV Care: HIV positive mothers - provide ART for the mother and adherence support; HIV negative mothers- HIV test every three months while breastfeeding	Other: Quality improvement intervention to strengthen health service provision; Quality improvement intervention comprising of regular improvement meetings based at clinics.
Active Comparator: Control; Routine maternal and child care service delivery	Other: Quality improvement intervention to strengthen health service provision; Quality improvement intervention comprising of regular improvement meetings based at clinics.

Outcome Measures

Primary Outcome Measures :

1. Quality of Maternal and Child Care [ Time Frame: 3 months ]
   Proportion of mother-baby pairs who received comprehensive care

Secondary Outcome Measures :

1. Quality of Child Care [ Time Frame: 3 months ]
   Proportion of babies who receive growth monitoring services
2. Quality of Maternal Care [ Time Frame: 3 months ]
   Proportion of mothers who receive feeding advice

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women who attended the clinic for maternal and child health care services.
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Women who attended the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Exclusion Criteria:

Women who did not attend the clinic for maternal and child health care services at 27 participating clinics from January 2016-February 2017.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haskins L, Chiliza J, Barker P, Connolly C, Phakathi S, Feeley A, Horwood C. Evaluation of the effectiveness of a quality improvement intervention to support integration of maternal, child and HIV care in primary health care facilities in South Africa. BMC Public Health. 2020 Mar 12;20(1):318. doi: 10.1186/s12889-020-8397-2.

• Responsible Party: Christiane Horwood, Senior Researcher, University of KwaZulu
• ClinicalTrials.gov Identifier: NCT04278612
• Other Study ID Numbers: UNIP123
• First Posted: February 20, 2020
• Last Update Posted: February 20, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD will not be shared
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)
• Time Frame: Anytime
• Access Criteria: We are more than happy to share our study protocol, statistical analysis plan or informed consent with anyone who is interested.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christiane Horwood, University of KwaZulu:

Quality improvement; Integrated care; Maternal health; Child health; HIV/AIDS; South Africa; Growth Monitoring; Child Growth; Nutrition